US11998583B2 - Fructus forsythiae and radix astragali compound preparation, and preparation method therefor and use thereof - Google Patents
Fructus forsythiae and radix astragali compound preparation, and preparation method therefor and use thereof Download PDFInfo
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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Definitions
- the present disclosure relates to a Fructus Forsythiae and Radix Astragali compound preparation, and a preparation method therefor and a use thereof, and relates to the technical field of medicines.
- Influenza (called the flu for short) is a respiratory tract infection mainly caused by influenza viruses, and is high in infectivity and spread rate.
- the typical clinical symptoms are fever, headache, limb soreness, sneezing, dry throat, sore throat, cough and weakness.
- the present disclosure provides a Fructus Forsythiae and Radix Astragali compound preparation, and a preparation method therefor and a use thereof.
- a Fructus Forsythiae and Radix Astragali compound preparation including traditional Chinese medicine formulation components.
- the traditional Chinese medicine formulation components consist of the following raw materials or raw material extracts in parts by mass: 9-11 parts of Flos Lonicerae, 9-11 parts of Fructus Forsythiae, 9-11 parts of Radix Scutellariae, 9-11 parts of Herba Artemisiae Annuae, 9-11 parts of Radix Astragali, 9-11 parts of stir-fried Rhizoma Atractylodis Macrocephalae, 9-11 parts of Herba Pogostemonis, 5-7 parts of Radix Saposhnikoviae, 9-11 parts of Radix Ophiopogonis, and 5-7 parts of Radix Glycyrrhizae.
- the traditional Chinese medicine formulation components consist of the following components in parts by mass: 10 parts of Flos Lonicerae, 10 parts of Fructus Forsythiae, 10 parts of Radix Scutellariae, 10 parts of Herba Artemisiae Annuae, 10 parts of Radix Astragali, 10 parts of stir-fried Rhizoma Atractylodis Macrocephalae, 10 parts of Herba Pogostemonis, 6 parts of Radix Saposhnikoviae, 10 parts of Radix Ophiopogonis, and 6 parts of Radix Glycyrrhizae.
- the Fructus Forsythiae and Radix Astragali compound preparation includes an effective dose of the traditional Chinese medicine formulation components and a pharmaceutically acceptable excipient.
- dosage forms of the Fructus Forsythiae and Radix Astragali compound preparation include an oral liquid, a granule, a dissolved medicine, and a tablet.
- a preparation method for a Fructus Forsythiae and Radix Astragali oral liquid including
- a preparation method for a Fructus Forsythiae and Radix Astragali granule including:
- a use of the Fructus Forsythiae and Radix Astragali compound preparation in preparation of medicines for preventing and/or treating a viral influenza disease is provided.
- monarch herbs include: Flos Lonicerae, Fructus Forsythiae, Radix Scutellariae, and Herba Artemisiae Annuae; minister herbs include: Radix Astragali, stir-fried Rhizoma Atractylodis Macrocephalae, and Herba Pogostemonis; assistant herbs include: Radix Saposhnikoviae and Radix Ophiopogonis; and an envoy herb is Radix Glycyrrhizae.
- the formulation has functions of clearing heat and removing toxic substances, inhibiting virus activity, nourishing yin and relieving cough, benefiting lung and tonifying spleen, strengthening body resistance and eliminating pestilence.
- the formulation is applicable to influenza, fever, headache, limb soreness, sore throat, cough and asthenia.
- beneficial effects of the Fructus Forsythiae and Radix Astragali compound preparation, and the preparation method therefor and the use therefor provided in the present invention are: firstly, pharmaceutical components of the formulation are different from those of the existing related traditional Chinese medicines, and the pharmaceutical composition of the formulation is unique and novel.
- an innovative point of efficacy of the drugs of the formulation lies in that by means of the pharmaceutical composition of the formulation, a strong medicine combined antiviral effect may be generated, and the immune function of the human body is further improved, so as to achieve a desirable integrated synergistic antiviral effect.
- Flos Lonicerae, Fructus Forsythiae, and Radix Scutellariae all have antiviral effects, and the three traditional Chinese medicines are used in combination in the formulation to enhance the medicine antiviral effect.
- Radix Scutellariae and Radix Glycyrrhizae in the formulation play a better integrated and synergistic antiviral effect by regulating the immune function of the human body, effectively inhibit virus activity, relieve symptoms of a patient, and achieve efficacy of strengthening body resistance and eliminating pathogens.
- a dialectical theory of the formulation on influenza treatment is unique and innovative, the innovative point is to propose “nourishing yin and relieving cough, benefiting lung and tonifying spleen, strengthening body resistance and eliminating pestilence” based on traditional heat clearing and toxic substance removing.
- Flos Lonicerae, Fructus Forsythiae, Radix Scutellariae, and Herba Artemisiae Annuae enter lungs, a stomach, a liver, a gallbladder and a large intestine meridian, and have effects of clearing heat and removing toxic substances, clearing lung heat and relieving cough;
- Radix Astragali, stir-fried Rhizoma Atractylodis Macrocephalae and Herba Pogostemonis have effects of benefiting qi and reinforcing spleen, and enhance resistance of the human body;
- compatibility of Radix Saposhnikoviae with Radix Astragali and Rhizoma Atractylodis Macrocephalae is Yupingfeng San, and achieves functions of tonifying qi, consolidating superficial resistance, enhancing the immune function of the human body, and strengthening the body resistance.
- Herba Artemisiae Annuae reduces fever, Herba Pogostemonis eliminates dampness with aromatics, and clears lung-heat and relieves coughing.
- Radix Ophiopogonis nourishes yin and promotes production of body fluid, nourishes the lung to arrest coughing.
- Radix Glycyrrhizae invigorates spleen and replenishes qi, clears heat and removes toxic substances, and regulates various drugs to exert a synergistic effect.
- Raw materials of a formulation are as follows: 100 parts of Flos Lonicerae, 100 parts of Fructus Forsythiae, 100 parts of Radix Scutellariae, 100 parts of Herba Artemisiae Annuae, 100 parts of Radix Astragali, 100 parts of stir-fried Rhizoma Atractylodis Macrocephalae, 100 parts of Herba Pogostemonis, 60 parts of Radix Saposhnikoviae, 100 parts of Radix Ophiopogonis, and 60 parts of Radix Glycyrrhizae.
- Raw materials of a formulation are as follows: 100 parts of Flos Lonicerae, 100 parts of Fructus Forsythiae, 100 parts of Radix Scutellariae, 100 parts of Herba Artemisiae Annuae, 100 parts of Radix Astragali, 100 parts of stir-fried Rhizoma Atractylodis Macrocephalae, 100 parts of Herba Pogostemonis, 60 parts of Radix Saposhnikoviae, 100 parts of Radix Ophiopogonis, and 60 parts of Radix Glycyrrhizae.
- a stock solution (15.6 g crude drug/kg) prepared from Fructus Forsythiae and Radix Astragali granules; ribavirin (positive control, 0.075 g/kg); and chicken embryo, influenza a virus FM1 strain, and ICR mice.
- mice are randomly divided into four groups, each group has six mice, and a normal group, a model group, a ribavirin group, and a Fructus Forsythiae and Radix Astragali granule group are set.
- the mice are intragastrically administered twice a day, 0.3 ml each time, and the mice in the normal group are administered with double-distilled water at the same dose for five consecutive days.
- the mice are infected intranasally with virus allantoic droplets, at 15 LD50 challenge doses per mouse.
- the mice are killed by cervical dislocation, fixed with a 10% formaldehyde solution, routinely sampled, dehydrated, embedded in paraffin, stained with HE, and read under a light microscope.
- the lesions are assigned as 0, 1, 2, 3 and 4 respectively.
- Lesion scores are computed and statistical analysis is performed. A rank sum test is used, and statistical software SPSS13.0 is used.
- Clinical efficacy criteria in 3 consecutive days of administration, body temperatures return to normal, symptoms of headache, limb soreness, dry throat, sore throat and cough are significantly relieved, and hemogram and chest X-rays are normal. Marked effect and relief are combined into effectivity, and the effective rate is up to 87%.
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Abstract
Description
-
- (1) preparing raw materials according to a formulation ratio: 10 parts of Flos Lonicerae, 10 parts of Fructus Forsythiae, 10 parts of Radix Scutellariae, 10 parts of Herba Artemisiae Annuae, 10 parts of Radix Astragali, 10 parts of stir-fried Rhizoma Atractylodis Macrocephalae, 10 parts of Herba Pogostemonis, 6 parts of Radix Saposhnikoviae, 10 parts of Radix Ophiopogonis, and 6 parts of Radix Glycyrrhizae; and washing the medicinal materials with water to remove impurities;
- (2) soaking the medicinal materials in deionized water at 25° C. for 120 minutes;
- (3) performing water extraction, and performing decocting at 100° C. for 20 minutes;
- (4) leaving a decoction to stand at 4° C. for 12 hours, filtering and concentrating the decoction, and adding benzoic acid or sodium benzoate; and
- (5) performing potting and sterilizing to obtain a Fructus Forsythiae and Radix Astragali oral liquid.
-
- (1) preparing raw materials according to a formulation ratio: 10 parts of Flos Lonicerae, 10 parts of Fructus Forsythiae, 10 parts of Radix Scutellariae, 10 parts of Herba Artemisiae Annuae, 10 parts of Radix Astragali, 10 parts of stir-fried Rhizoma Atractylodis Macrocephalae, 10 parts of Herba Pogostemonis, 6 parts of Radix Saposhnikoviae, 10 parts of Radix Ophiopogonis, and 6 parts of Radix Glycyrrhizae; and washing the medicinal materials with water to remove impurities;
- (2) soaking the medicinal materials in deionized water at 25° C. for 120 minutes;
- (3) performing water extraction, and performing decocting at 100° C. for 20 minutes;
- (4) leaving a decoction to stand at 4° C. for 12 hours, filtering and concentrating the decoction, and adding benzoic acid or sodium benzoate; and
- (5) performing drying, granulating, packaging and sterilizing to obtain a Fructus Forsythiae and Radix Astragali granule.
-
- (1) washing medicinal materials with water to remove impurities;
- (2) preparing the medicinal materials into 1000 parts by volume and soaking same in deionized water at 25° C. for 120 minutes;
- (3) performing water extraction, and performing decocting at 100° C. for 20 minutes;
- (4) leaving a decoction to stand at 4° C. for 12 hours, filtering and concentrating the decoction, and adding benzoic acid or sodium benzoate; and
- (5) potting and sterilizing to obtain a Fructus Forsythiae and Radix Astragali oral liquid.
-
- (1) washing medicinal materials with water to remove impurities;
- (2) preparing the medicinal materials into 1000 parts by volume and soaking same in deionized water at 25° C. for 120 minutes;
- (3) performing water extraction, and performing decocting at 100° C. for 20 minutes;
- (4) leaving a decoction to stand at 4° C. for 12 hours, filtering and concentrating the decoction, and adding benzoic acid or sodium benzoate; and
- (5) drying, granulating, packaging and sterilizing to obtain a Fructus Forsythiae and Radix Astragali granule.
| Lesion score | ||
| Hemorrhage and | |||||
| congestion of lung | Suppurative | Interstitial | |||
| Group | tissue | bronchitis | Bronchitis | Alveolitis | pneumonia |
| Normal group | 0 | 0 | 0 | 0 | 0 |
| Model group | 12 | 18 | 15 | 13 | 8 |
| Ribavirin group | 7 | 9 | 3 | 3 | 2 |
| Fructus Forsythiae | 3 | 9 | 5 | 6 | 7 |
| and Radix Astragali | |||||
| granule group | |||||
| Note: | |||||
| (1) In different tissue lesions, differences between the model group, the ribavirin group and the Fructus Forsythiae and Radix Astragali granule group and the normal group have statistical significance (P < 0.05). | |||||
| (2) Differences between the ribavirin group and the Fructus Forsythiae and Radix Astragali granule group have no statistical significance (P > 0.05). | |||||
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| CN202010168799.0A CN111249390B (en) | 2020-03-12 | 2020-03-12 | A compound preparation of Qiqi and its preparation method and use |
| PCT/CN2020/101945 WO2021179505A1 (en) | 2020-03-12 | 2020-07-14 | Forsythia suspensa and astragalus membranaceus compound preparation, preparation method therefor and application thereof |
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| CN111249390B (en) * | 2020-03-12 | 2025-07-04 | 尧舜泽生物医药(南京)有限公司 | A compound preparation of Qiqi and its preparation method and use |
| CN113577140A (en) * | 2021-07-28 | 2021-11-02 | 黑龙江中医药大学附属第一医院(黑龙江中医药大学第一临床医学院) | Traditional Chinese medicine composition for treating neocoronary pneumonia and preparation method and application thereof |
| CN113925835A (en) * | 2021-09-29 | 2022-01-14 | 孙鲁英 | Exterior-strengthening lung-clearing granules and preparation method thereof |
| CN114606236B (en) * | 2022-04-21 | 2024-01-05 | 南通大学 | Micro ribonucleic acid from Chinese medicinal decoction of radix astragali, and preparation method and application thereof |
| CN118384239A (en) * | 2022-12-12 | 2024-07-26 | 北京揆正中医药科技有限公司 | A composition for strengthening the body and preventing and treating COVID-19 and a preparation method thereof |
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| CN104740370A (en) * | 2013-12-26 | 2015-07-01 | 孔辉 | Drug for preventing and treating avian influenza |
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| CN101816752B (en) * | 2009-02-26 | 2011-08-31 | 河南天纳图生物科技有限公司 | Traditional Chinese medicament for preventing and treating avian influenza |
| CN101574407B (en) * | 2009-06-24 | 2011-04-13 | 贾高增 | Drug for preventing cold and preparation method thereof |
| CN101708275B (en) * | 2009-11-27 | 2012-11-28 | 北京市卫生局临床药学研究所 | Chinese medicament for treating flu caused by influenza A(H1N1) and the like |
| CN104013678B (en) * | 2014-05-24 | 2016-02-17 | 潍坊市富言畜禽病诊疗中心 | A kind of Chinese medicine composition for preventing and treating bird flu, newcastle |
| CN104840786B (en) * | 2015-05-14 | 2019-02-15 | 北京康华远景科技股份有限公司 | A kind of pharmaceutical composition and preparation method thereof of pre- avian influenza-prevention |
| CN109939152A (en) * | 2017-12-20 | 2019-06-28 | 广东恒诚制药有限公司 | A kind of preparation method and application for cough-stopping granule of catching a cold |
| CN111249390B (en) * | 2020-03-12 | 2025-07-04 | 尧舜泽生物医药(南京)有限公司 | A compound preparation of Qiqi and its preparation method and use |
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| CN104740370A (en) * | 2013-12-26 | 2015-07-01 | 孔辉 | Drug for preventing and treating avian influenza |
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| Gu, S., et al., Antitumor, Antiviral, and Anti-Inflammatory Efficacy of Essential Oils from Atractylodes macrocephala Koidz. Produced with Different Processing Methods, Molecules 2019, 24(16), 2956 (Year: 2019). * |
| Gu, S., et al., Understanding molecular mechanisms of traditional Chinese medicine for the treatment of influenza viruses infection by computational approaches, Mol. Bio Syst., 2013, 9, 2696 (Year: 2013). * |
| Machine translation of CN-104740370-A Description (2023). * |
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| JP2023508675A (en) | 2023-03-03 |
| EP4066848A4 (en) | 2023-01-04 |
| JP7560154B2 (en) | 2024-10-02 |
| EP4066848A1 (en) | 2022-10-05 |
| EP4066848B1 (en) | 2025-11-26 |
| CN111249390B (en) | 2025-07-04 |
| CN111249390A (en) | 2020-06-09 |
| WO2021179505A1 (en) | 2021-09-16 |
| US20230040479A1 (en) | 2023-02-09 |
| KR20220098360A (en) | 2022-07-12 |
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